MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN MINT FLOSS; DENTAL FLOSS

Lot Number 0197D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 15-may-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2017 from a consumer (age and gender unspecified) reporting on self from united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally for general oral hygiene (lot number 0197d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the cutter broke off when consumer was pulling the floss over for dispensing which the consumer described as packaging issue.The consumer stated to have opened a lid to see metal cutter and it was intact, it broke and popped off while pulling the floss.The consumer further mentioned that the insert of the floss stayed connected.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

The date of this submission is 15-jun-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 01-may-2017 from a consumer (age and gender unspecified) reporting on self from united states of america.On an unspecified date, the consumer started using listerine ultraclean mint floss, dentally for general oral hygiene (lot number 0197d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the cutter broke off when consumer was pulling the floss over for dispensing which the consumer described as packaging issue.The consumer stated to have opened a lid to see metal cutter and it was intact, it broke and popped off while pulling the floss.The consumer further mentioned that the insert of the floss stayed connected.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states of america.Additional information was received on 06-jun-2017.A review of complaint data revealed no unfavorable trends for the reported lot number.Device history records were reviewed and no deviations or non-conformances were noted.Visual inspection was performed on the retain samples and all results met specification.Product met specification as documented in the records and retain sample reviewed.Based on the information available, the device was used for intended treatment.The analysis of product and complaint category trend will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal ; DR
• Manufacturer Contact: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6566200
• MDR Text Key: 75234174
• Report Number: 8041101-2017-00017
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0197D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1